CN113692296A

CN113692296A - Airway management device and method for manufacturing object

Info

Publication number: CN113692296A
Application number: CN202080027308.9A
Authority: CN
Inventors: R·C·怀特
Original assignee: R CHuaite
Current assignee: R CHuaite
Priority date: 2019-02-08
Filing date: 2020-02-05
Publication date: 2021-11-23
Also published as: EA202192171A1; CA3129630A1; AU2020218724A1; JP2022522633A; SG11202108643WA; US20220118206A1; EP3921006A1; WO2020162832A1; EP3921006A4; KR20210148107A

Abstract

An airway management device having a body (6), the body (6) comprising a shell molded from a polypropylene copolymer (PP) blended with a thermoplastic elastomer (TPE) styrene-ethylene/butylene-styrene (SEBS), the shell extending from a proximal opening to a distal tip of the body (6), the shell having a curved portion (35) and a straight portion (37). A method of manufacture is also disclosed.

Description

Airway management device and method for manufacturing object

Cross Reference to Related Applications

This application claims priority from U.S. provisional patent application No. 62/803,122, the disclosure of which is incorporated herein by reference. All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

Background

Laryngeal Mask Airways (LMA) have become an alternative to endotracheal tubes or masks for managing the airway during general anesthesia. "classic" LMA (CLMA) is an artificial airway device made of Liquid Silicone Rubber (LSR) that includes a curved or flexible tube open at one end to the interior of an oval hollow and inflatable mask portion that fits and functions to occupy the space behind the larynx and to seal around the perimeter of the laryngeal inlet. The device does not penetrate the interior of the larynx and therefore vocal cord injuries are avoided. A meta-analysis of The 858 publication directed to CLMA (Brimaccombe, "The advantages of The LMA over The traditional tube or mask: meta-analysis" ("LMA advantages over endotracheal tubes or masks"), Can J Anaesth (Canadian J. Canada. inebriety), 1995; 42: 1017-23) determined that CLMA provides faster speed and easier placement, hemodynamic stability and improved oxygen saturation compared to endotracheal tubes (ETT) and masks (FM). The single greatest drawback of CLMA is the higher frequency of gastric insufflation compared to ETT, while for FM, the single greatest drawback is gastroesophageal reflux (GOR). Overall, it is noted that the insertion technique may not be well defined, and therefore sub-optimal positioning may affect the result. It is also noted that CLMA results in an increase in work of breathing (WOB) compared to ETT.

Later studies (Roux M, Drolet P, Girard M, Grenier Y, Petit B, "Effect of the large mask air available on oesophageal pH: influence of the volume and pressure inside the cuff" ("influence of laryngeal mask airway on oesophageal pH"; Br J Anaesth (J. Anaesthetics), 1999 month 4; 82 (4): 566-9) confirmed: by comparing the pH level of the esophagus during anesthesia, the incidence of GOR was higher with CLMA compared to using a mask and oropharyngeal airways. When CLMA was used, it was evident that the average pH in the lower part of the esophagus decreased and the percentage of time that the pH was below 4.0 increased. There is no definite correlation between cuff pressure or inflation volume and GOR incidence.

Further studies (Reissmann H, Pothmann W, FCilliekrag B, Dietz R, Schulte am Esch J, "(Resistance of laryngeal mask airway and tracheal tube in mechanically ventilated patients)," British Journal Anaesth (J. Anaesthetics), Vol.85, No. 3, 9/1/2000, page 410-. Although the airflow resistance of an LMA of size 4 should be less than that of an ETT of the appropriate size (8.5mm inner diameter), the average airflow resistance of the CLMA together with the larynx is not clinically relevant differences compared to the ETT due to the large variability in the anatomy between the LMA and the trachea that seals against the laryngeal opening. Furthermore, the study concluded that the presence of CLMA in the laryngo pharynx may actually alter the geometry of the upper airway, resulting in a narrowing of the glottic opening, further increasing airflow resistance.

Brain discloses an Intubating Laryngeal Mask Airway (ILMA) in US patent No. US 6079409A. The CLMA flexible airway tube was replaced with an anatomically curved large bore stainless steel tube equipped with a proximal guide handle. The conclusion of Brain et al was that in preliminary evaluations, ILMA appeared to be an effective ventilator and intubation guide for both conventional and difficult airway patients who did not have The risk of gastric aspiration (Brain AIJ, Verghese C, Addy EV, Kapila a, Brimacombe j., "The intubating large mask.ii: a advanced clinical report of a new way of endotracheal intubation", "journal of anesthesia in england, volume 79, phase 6, 1997, 12.1.709", compared to standard CLMA, ILMA was configured with airway tubes of larger diameter but shorter length, rigid enough to guide ETTs of appropriate length through The mask and into The glottic 150 patients (99.3%) using 149 patients, where The successful intubation in 75% of patients had a known airway obstruction or obstruction in The first attempt, ILMA requires much fewer adjustment operations. The ETT used in the study was a prototype, characterized by a straight cuff and a flexible silicone tube.

Located in the laryngopharynx and forming a barrier at the upper oesophageal sphincter (OES), CLMA and its deformation have the major limitation that the patient's lungs cannot be reliably protected from reflux of gastric contents (Keller C, Brimacombe J, Bittersohl J, Lirk P, von Goedecke a., "Aspiration and the large tissue mask airway: three cases and literature reviews" ("Aspiration and laryngeal mask airway"; journal of anesthesia in uk, volume 93, phase 4, day 10 and 1 2004, page 579 and 582). Keller et al evaluated three cases of aspiration using LMA, in which bile-stained fluid was removed from the trachea. In each case, LMA was replaced by ETT. In one of these cases, ILMA was used, but aspiration could have occurred before intubation had not been performed. Thus, a prior assessment of the risk of aspiration is considered to be crucial in determining whether and if so which type of LMA should be used. ILMA has documented increased oropharyngeal leakage pressure compared to CLMA, but pharyngeal mucosal pressure is higher and exceeds capillary perfusion pressure. Thus, ILMA are not suitable as a conventional Airway management device and should be removed after intubation is complete (Keller C, Brimacombe J., "pharmaceutical nasal Pressures, air Sealing Pressures, and fiber positioning with the introduction of the Standard Laryngeal Mask Airway pressure, Airway seal pressure, and fiber Position using intubation VS)," anesthesiology ", 1999, 4 th, volume 90, page 1001 and 1006). Supraglottic airway devices (where "Supraglottic" means "over the larynx") have been classified into first or second generation (Cook T, Howes b., "Supraglottic air access devices: recourse" ("Supraglottic airway device: recent developments"), connecting efficacy in anal clinical Care & Pain,

volume

11, 2 nd, 2011, 4/1/2011, pages 56-61). Thus, CLMA and ILMA are referred to as first generation SAD (i.e., supraglottic airway device) because neither of them can prevent gastric aspiration.

The LMA "Proseal" (PLMA) described in us patent application publication No. 2012/0211010a1 is a second generation SAD in that it is equipped with a built-in Gastric Drainage (GD) catheter, whereby The digestive and respiratory tracts are separated, allowing gastric juices to enter or escape, reducing The risk of gastric insufflation and pulmonary aspiration (Brain AIJ, Verghese C, Strube PJ., "The LMA 'Proseal' -a laryngel mask with an oesophageal vent" ("LMA 'Proseal' -laryngeal mask with oesophageal outlet"), "british journal of anesthesia, volume 84, phase 5, month 2000, page 650-654). It is recognized that in a resting state, the laryngo pharynx is normally closed, however, any SAD that occupies the laryngo pharynx sufficiently to form an esophageal seal and provide GD must open the esophagus and, in doing so, push the glottis forward (O' Neil MJ., "Mechanical closure of the vocal cords with the LMA ProSeal" ("Mechanical closure of vocal cords using LMA ProSeal)," british journal of anesthesiology, 2002, vol 89, No. 6, p. 936-937). Brimacombe et al reported that vocal cord closure was associated with a reduction in the anteroposterior diameter of the glottic entrance when using PLMA in patients with complete paralysis (Brimacombe J, Richardson C, Keller C, Donald S., "Mechanical closure of the vocal cords with the professional synthetic mask airway" ("Mechanical closure of vocal cords with the professional laryngeal mask airway"), "British Magnetics, 2002; 89: 296-7). It is assumed that the mechanism of vocal cord closure is caused by an inflatable cuff that presses the glottic entry along the anterior-posterior axis, thereby reducing the tension of the vocal cords and causing the arytenoid cartilage to rotate inward and cause the cords to close. Although not specifically described for over inflation of the cuff, the withdrawal of air from the cuff and moving the patient's head to the inspiratory position reduces the compressive force on the glottis, allowing the arytenoid cartilage to rotate outward and the vocal cords to open. Brimacombe noted that 4 of 915 paralyzed patients treated with PLMA (0.4%) developed mechanical vocal cord closure and 17% developed some degree of epiglottic fold down, but rarely caused airway obstruction due to the auxiliary exit port below the drainage tube. In another reported case, (Ghai A, Hooda S, Wadhera R, Kad N, Garg N., "Failed ventilation with LMA patient in a patient with sleep apnea syndrome" ("LMA patient Failed to ventilate using LMA patient' S), Anaesth Pain & Intelligent Care 2013; 17 (1): 94-96), after several attempts to overcome the failure to ventilate, the researcher removed the PLMA and replaced the PLMA with a replacement device. The authors cite an article by Stacy et al (Stacy MR, Sivasankar R, Bahlmann UB, Hughes RC, Hall JE., "Mechanical closure of the local records with the air management device" using the airway management device, J. Anaesthetics, 2003; 91: 299) which reports an incidence of airway obstruction of 20% similar to SAD. Stacy et al assume either epiglottis fold down or mechanical vocal cord closure. Insertion of the PLMA beyond its optimal position results in almost complete obstruction of the airway, possibly due to forward displacement of the glottic entrance.

LMA "Supreme" (SLMA), disclosed in us patent application publication No. 2012/0145160a1, is also a second generation SAD characterized by an inflatable cuff and an esophagogastric drainage catheter (GD), but which is a disposable device made of semi-rigid PVC (polyvinyl chloride) and vinyl elastomer. A case study by Bergmann et al evaluated two methods of cuff inflation and device fixation for SLMA to determine The effect on oropharyngeal leakage pressure, The location of The distal tip in The laryngopharynx, gastrointestinal and respiratory tract separation, and perioperative airway morbidity (Bergmann I, Crozier TA, Rosssler M, Schotta H, Mansur A, Buttner B, Hinz JM, Bauer M., "The effect of changing The sequence of cuff inflation and device setting with The same

on device position, vehicle compatibility, and air mobility: a clinical and fibrous student "(" use of

The effect of varying the sequence of cuff inflation and device fixation on device position, ventilation complications, and airway morbidity: clinical and fiberoptic studies, "BMC Anesthesiology, 2014; 14: 2,2014, 1 month 4 day on-line, doi: 10.1186/1471-2253-14-2). The control method was the manufacturer's recommended sequential insertion, cuff inflation and device fixation method. An alternative "research" approach is to secure the device prior to cuff inflation. No incidence of hypoventilation or incorrect positioning, oropharyngeal leakage pressure, end position, and gastrointestinal tract were observedA clear difference in the tract and respiratory tract. Importantly, glottic stenosis also occurs at the same frequency. However, the incidence of glottic stenosis with airway obstruction was significantly higher in the control group than in the study group. The sore throat, hoarseness, SLMA hemogram and dysphagia were significantly higher than the control group. Another study comparing PLMA to SLMA (Lopez AM, Valero R, Hurtado P, Gambus P, Pons M, Anglada T., "Comparison of the LMA Supreme with the LMA procedure for administration of airway in patients with prone anesthesia", "J. Anaesthetics & LMA Proseal," 107 (2): 265-71(2011)) concluded that PLMA requires less manipulation and exhibits slightly higher oropharyngeal leak pressure despite similar first insertion rates of the two devices. Laryngeal spasm in both devices has a similar incidence and was successfully treated by increasing the depth of anesthesia and administering neuromuscular blocking agents when needed. Laryngeal spasm (novel G, Walker RWM, "Laryngospasm in anal spasm" ("laryngeal spasm in anesthesia"), Continuing Edurion in anal Christial Care&Pain, vol 14,

stage

2, 4/1/2014, pages 47-51) is described by a continuous closure of the vocal cords, resulting in partial or complete loss of the patient's airway. This is an initial reflex that prevents aspiration, but can be problematic under general anesthesia. Thus, it can be concluded that the pathogenesis of glottic stenosis or vocal cord closure can be mechanical or physiological, the latter being the result of innervation during SAD insertion or if the degree of anesthesia is less.

I-gel is another second generation SAD characterized by a non-inflatable cuff and the possibility of introducing a gastric tube (Theiler L, Gutzmann M, Klein-Brueggeney M, Urwyler N, Kaempfen B, Grief R., "I-gel^TMsupra systematic air in clinical practice: a reactive outcome multiple study "(" I-gel in clinical practice)^TMSupraglottic airway: a prospective observational multicenter study, journal of anesthesia in the united kingdom, 109 (6): 990-5(2012)) to expel gastric juice. It relies on a soft SEBS (styrene-ethylene/butylene-styrene) gel-like mass of the cuffThe texture is consistent with the anatomical differences of the laryngeal inlet. The authors noted that the difficulty that occurred during insertion was due to the volume of the non-inflatable cuff, i.e., it did not deflate to a flat profile to facilitate passage through the teeth and tongue. Insertion and subsequent fixation causes the tongue to protrude outward and become tightly clamped between the teeth and the proximal end of the relatively straight airway tube.

Studies on the effectiveness of I-Gel sealing on cadavers compared to PLMA and SLMA have shown that when the distal cuffs of PLMA and SLMA are properly placed in the laryngo pharynx, the corresponding sealing pressure is three and two times that of I-Gel (Schmidbauer W, Bercker S, Volk T, Bogusch G, Mager G, Kerner T., Oesophageal seal of the novel subarynagal access I-Gel^TMin comparison with the laryngeal mask airways Classic^TMand ProSeal^TMuse a cadover model "(. Classic with laryngeal mask airway Using cadaver model)^TMAnd ProSeal^TMOesophageal seal of a comparable new laryngeal upper airway device I-gel), "journal of anesthesia in uk, vol 102, phase 1, 1/2009, p 135-. Although cadavers do not accurately represent humans, the study emphasizes that SAD does not prevent aspiration as reliably as ETT does. Magnetic resonance imaging studies by Russo et al on the in vivo location of the I-gel compared to SLMA have shown that both devices have a significant effect on glottis, and SLMA is even more pronounced because the inflated cuff is larger (Russo SG, Cremer S, Eich C, Jipp M, Cohnen J, Strack M, Quintel M, Mohr A., "Magnetic resonance imaging student of the in vivo location of the extra cementitious devices I-gel^TMand LMA-Supreme^TMin analesthemized human volnters "(" external glottic airway device for anaesthetising human volunteers I-gel^TMAnd LMA-Supreme^TMMagnetic resonance imaging studies at the in vivo location of (1), (journal of anesthesia, uk), month 12, 2012; 109(6): 996-1004). SLMA extends deeper into the UOS, while I-gel causes greater swelling in the upper layers of the UOS. The SLMA's anatomical airway had little effect on the tongue soft tissue, while the straighter and semi-rigid I-gel compressed the tongue, resulting in higher mucosal pressure. Although it is possible to cannulate through I-gelThe airway, which is relatively straight with I-gel, lacks anatomical curvature, reducing its first intubation rate compared to ILMA.

In addition to the mechanical closure of the vocal cords, the lingual (Brimacombe J, Clarke G, Keller C. Lingulal neural injury with the ProSeal laryngel mask air aid: a case report and review of performance (lingual nerve injury Associated with ProSeal laryngeal mask Airway: case report and review of literature), "British Magnetics, 2005; 95: 420-3), sublingual and laryngeal back (Michael P, Donaldson W, Votrubo E, Hakl M.Compounds Association with the Use of the supervisory air device in the Perioperative period of Medicine, cuff (cuff) Associated with the Use of Supraglottic Airway device in Perioperative period of Medicine, International medical research, International biological research, laryngeal Devices in medical treatment, cuff (cuff) is numbered in relation to the lingual nerve injury or the most applicable nerve injury (cuff) and is numbered in relation to the case of the sublingual nerve injury, or is numbered in relation to the case of the sublingual nerve injury (7413) and is reported in relation to the case of the sublingual nerve injury Contributing factors: the selected PLMA (polymethylmethacrylate) is too small in size and therefore the cuff is too small in size; secondly, nitrous oxide was used. Over-inflating an undersized cuff to improve the sealing effect and gradual increase of nitrous oxide diffusion within the cuff (Cross AM, Pitti R, Conil C, Giraud D, Verhulst J. Severe Dysphonia after Use of a Laryngel Mask (Severe Dysphonia after Use of Laryngeal Mask), (Anaesthetics, 1997; 86: 497 + 500) increases the cuff pressure, especially if the procedure time is extended. With respect to laryngeal nerve injury, michaek et al concluded that the cause of nerve injury is multifactorial, with the cuff being an important contributing factor, either being too stiff during insertion or pressing directly against the nerve structure when in place.

Compared to ETT, CLMA cannulae provide faster speed and easier placement, hemodynamic stability, and better oxygen saturation. However, it does not reliably protect the lungs from regurgitation of gastric contents. Variations of CLMA include ILMAs configured with larger diameter and shorter airway conduits that are sufficiently rigid to guide the flexible ETT through the mask and into the glottis. Endotracheal intubation using ILMA has been successful but does not provide an inlet or leak for gastric contents to reduce the risk of lung aspiration. Furthermore, it is not recommended to use it as a conventional airway device.

First insertion rate, cuff overinflation, and incorrect positioning are often mentioned in the literature. In describing the relationship of cuff pressure to volume, Bick et al (Bick E, Bailes I, Patel A, Brain Al. Power cord throats and a beta seal: why medication management for large mask air weights of the standard of care) ("less sore throat and better seal: why conventional manometry of the laryngeal mask airway must be the standard of care)," Anaesthetics, "2014 12 months; 69 (1304-8) demonstrated positive and negative recoil when an inflatable cuff changes from negative elastic recoil at low volume to high volume. The recommended inflation volume for a CLMA size of 4 is 30ml without distorting or dilating the LSR cuff material. The pharynx, although less rigid than the trachea, does significantly prevent dilation. Once inserted, it was concluded that the amount of inflation to maintain satisfactory oropharyngeal leakage pressure was actually less than 30ml, and thus this evidence suggests that sore throat is associated with excessive cuff pressure. Increased mucosal pressure and non-conformity with the contours of the larynx, pharynx and oesophagus are also direct consequences of hyperinflation. The presence of an LMA in the laryngo pharynx alters the geometry of the upper airway, resulting in a narrowing of the glottic opening, further increasing airflow resistance and increasing WOB compared to endotracheal tubes.

It can be concluded that the characteristic large volume construction of second generation SAD made of liquid silicone rubber (such as PLMA) or polyvinyl chloride elastomer (such as SLMA) plays an important role in the pathogenesis of vocal cord closure and the cause or etiology of nerve injury. With respect to PLMA, U.S. patent application publication No. 2012/0211010a1 (page 1, paragraph 005) teaches that the drainage catheter tube must be sufficiently rigid at its distal end to withstand the pressure of the inflated cuff, and it has been found that this may make it more difficult to properly insert the deflation device into the throat of the patient, as necessary or desired.

U.S. patent application publication No. 2012/0211010a1 discloses reinforced tailgates 27 that have been thickened relative to the first generation SAD (page 9, paragraph 0111). Including an inflatable volume depicted as a back cuff 65 (fig. 7 and 8) formed by a flexible panel 62 (page 4, paragraph 0051) overlying the backplate 27 and bonded to the back of the main cuff 40 along the perimeter 63. The main cuff 40 and the back cuff 65 are interconnected for simultaneous inflation. After inflation, the pressure within the back cuff 65 presses against the elliptical portion of the backplate 27 causing it to bulge forward and potentially displace the internal drainage catheter 115 forward. To improve this situation, the reference teaches that the tailgate must be thickened and molded using a higher durometer Liquid Silicone Rubber (LSR) material than the first generation SAD tailgate. To offset the added bulk of this construction, the flexible panel 62 is molded as a thin sheet of LSR that can stretch significantly in response to internal inflation pressure.

Functionally (page 9, paragraph 0108), inflation of the main cuff 40 causes expansion of the distal region 45, enabling it to abut against and conform to the pharynx 197 and the laryngo pharynx 212. Upon further inflation, the rear cuff 65 causes initial engagement between the flexible panel 62 and the posterior surface of the pharynx 197. The pressure within the rear cuff 65 pushes the main cuff 40 forward, compressing the tissue surrounding the laryngeal inlet 67. This enhances the sealing engagement between the main cuff 40 and the tissue surrounding the laryngeal inlet 67, thereby reducing leakage between such tissue and the main cuff 40. Page 4, paragraph 0051, describes an initial description of this configuration in the installed and inflated state. Specifically, an increased anteroposterior space characterized by a minimum depth of 10mm (page 9, paragraph 0109) is measured between the anterior tangent of the internal drainage catheter 115 and the plane described by the anterior surface of the main cuff 40 (FIG. 9 "b"). To maintain the desired anterior-posterior dimension, the distal aperture 123 must be wedged into the upper esophageal sphincter such that the inner drainage catheter 115 is surrounded by the annular inflation volume after inflation of the main cuff 40.

Furthermore, U.S. patent application publication No. 2012/0211010A1 teaches that over inflation of the back cuff 65 (page 9, paragraph 0109) will cause the elliptical portion 87 of the backplate 27 to bulge forward, causing the internal drainage tube 115 to shift relative to the main cuff 40 and lose the anterior and posterior space previously described. If this anteroposterior space is reduced below a minimum level, the internal drainage catheter may impinge on the anatomy of throat 32, throat 32 typically being present in throat area 110. Thus, the reported cases of vocal cord closure are related to the reduction in anterior-posterior diameter of the glottic portal when using PLMA.

Similarly, the SLMA of U.S. patent application publication No. 2012/0145160a1 (page 1, paragraph 0010) provides a gastric drainage opening at the distal end of a mask that can be applied to directly serve the laryngo pharynx, which results in such masks becoming bulky and overly stiff, thereby making it difficult to properly insert the mask. In particular, (page 2, paragraph 0013) in any such device, regardless of the material from which it is made, the addition of esophageal drainage itself adds significant manufacturing complexity and also affects the device's performance in terms of ease of insertion, seal formation, and prevention of insufflation.

This complexity is further exacerbated by the use of PVC or similar high performance adhesive polymers. The tacky polymers have a coefficient of tack or strain rate that varies with time. The release of energy is not immediate, but rather varies over time after the load is applied and then removed. During insertion and subsequent manipulation of the SAD by various methods (not limited to rotation and tilting), this characteristic viscosity coefficient leads to backward folding and excessive folding of the main cuff or the distal portion of the cuff, such as the anal and respiratory apparatus operators-superior tissue aids and conditioners, ISO 11712: 2009(E) (anesthesia and breathing apparatus-upper laryngeal airway and connectors, ISO 11712: 2009 (E)). The result of such folding is incorrect seal formation and a high probability of blow-through.

Furthermore, the need to provide a drainage catheter that seals against the airway and passes through an inflatable cuff presents particularly difficult problems. The provision of a drainage conduit can result in unacceptable stiffening of the end region of the mask and obstruction and/or restriction of the airway passage with respect to functional impact. The relatively rigid PVC airway tube 2 of SLMA (page 3, paragraph 0049) includes grooves or channels 20 that are configured on either

side

18 and 19 of the airway tube 2 (fig. 1, 3, and 10) to improve flexibility during insertion and prevent kinking. The esophageal drainage catheter 41 is inserted into the airway tube 2 (page 4, paragraph 0062) and secured to the connector body 43 at the proximal end and the backplate 4 at the distal end by adhesive. This provides fluid communication in the small bore 49 separate from fluid communication in the large bore 48 (i.e. the interior of the airway tube 2). The addition of ribs and channels increases the volume of the assembled device 1, and the external grooves and channels (20) form ridges along the inner surface of the airway tube sides, reducing the internal volume of the airway tube 2. The esophageal drainage catheter 41 occupies the median plane of the interior space. Aligned with the connector body 43 and the plug 45 and adhesively bonded to the connector body 43 and the plug 45, the configuration of the esophageal drainage catheter 41 effectively obstructs intubation.

The alternative SAD with a non-inflated cuff shows less glottic shift with correspondingly lower esophageal seal pressure. In this case, the coarse airway does not provide anatomical curvature and may press the tongue, causing the tongue to bulge outward with subsequent rise in mucosal pressure. Although cannulation is possible, the maximum dimension of the ETT is less than the recommended dimension for the same weight, e.g., an I-gel of dimension 4 accommodates an ETT with an inner diameter of 7.0mm, while the recommended ETT inner diameter for the same body mass is 8.0mm to 8.5 mm.

Typically, the esophageal drainage catheter must be passed through an inflatable cuff, which presents particularly difficult manufacturing problems. Furthermore, the provision of the discharge conduit produces unacceptable stiffening of the distal tip, affecting the performance in terms of ease of insertion, formation of the seal and prevention of insufflation. The semi-rigid PVC and PVC elastomers commonly used for disposable SAD's exacerbate the difficulties described above, as acceptable flexural performance requires increased thickness, which in turn results in bulkiness.

Nevertheless, there remains a need for a single-use SAD that can combine gastric drainage of an appropriately sized ETT with tracheal intubation through an anatomically curved airway, and that can also be used as a conventional airway management device; and in contrast to past approaches, the volume of the device can be significantly reduced by not exposing the esophageal drainage catheter (otherwise known as a gastric drainage catheter) to the inflation pressure within the cuff.

WO2015119577 describes an airway management device comprising a body having a distal end and a proximal end for receiving an oxygen supply tube. To reduce the volume of the distal end, the overall device must be scaled down. This eliminates the use of adhesives and redefines the manufacturing method and material selection. Past approaches have proposed passageways or conduits for fluid communication as separate or independent components. No attempt has been made to combine these passageways so that their wall thickness and characteristics can be shared, thereby reducing overall volume. The rheological relationship between polyolefins such as polypropylene (PP) and the block copolymer SEBS (styrene-ethylene/butylene-styrene) has not been fully exploited, except that the cuff portion of the SAD is restricted to a gel-like substance that cannot be deflated to facilitate insertion (I-gel). SEBS is a thermoplastic elastomer (TPE) characterized by hard and soft domains in individual polymer strands. The terminal block of these strands is a crystalline styrene and the middle block is a soft ethylene-butylene block. These strands join at the styrene end blocks to form physical crosslinks that provide rubber-like elasticity.

Accordingly, a need has been identified for an improved airway management device that overcomes some or all of the above limitations or other limitations yet to be discovered.

Disclosure of Invention

According to one aspect of the present disclosure, an airway management device is provided. In one embodiment, the device includes a body including a shell molded from a polypropylene copolymer (PP) blended with a thermoplastic elastomer (TPE) styrene-ethylene/butylene-styrene (SEBS), the shell extending from a proximal opening to a distal tip of the body, the shell having a curved portion and a linear portion.

In some embodiments, the device further comprises a middle strip molded from polypropylene copolymer (PP). The intermediate strap may be attached to the housing intermediate the curved portion and the linear portion.

In some embodiments, the device may further include a first SEBS overmold that includes a rear profile and a distal profile on the housing. The first overmolded portion may include a distal perimeter defining first opposing edges of an overmolded cuff membrane extending tangentially from the perimeter in an annular curve having end points in spaced relation to and orthogonal to the first opposing edges, the end points defining an open rear perimeter or second opposing edges and a straight portion overmolded proximal end, such that the curved portion and the straight portion are joined into a single molded piece with a planar sealing void of the first and second sides of the intermediate strip. The second SEBS overmold may close the open length of the membrane, forming an inflatable cuff.

In some embodiments, the rear contour of the body is adapted to be located within the laryngo pharynx and the distal end is adapted to be located within the upper esophageal sphincter, forming an esophageal seal immediately above the distal opening. The forward compound curvature of the housing is the interior posterior surface of the channel or gastric drainage catheter, thereby reducing the volume of the distal tip. The device may further include a circumferential contour that overmolds the anterior compound curvature of the housing and is adapted to be positioned and pressed against the laryngo pharynx, a full distal to proximal configuration of the housing providing resistance against upward displacement of the distal opening due to increased esophageal pressure. The drainage catheter and the drainage catheter distal opening may be integral with a distal posterior profile not surrounded by the annular volume of the inflatable cuff.

The closed tubular section of the device may form a lumen to provide space for the distal portion of the inflatable cuff to displace rearwardly upon inflation. In some embodiments, a first edge and a second edge are provided through any horizontal cross section of the inflatable cuff, at least for the length of the distal portion of the gastric drainage catheter. The edges can be substantially or approximately parallel to a median plane of the curved portion such that a width between the first edge and the second edge after the second overmolding is equal to an outer diameter of the distal drainage catheter. The curvature of the inflatable cuff membrane between the first edge and the second edge is a single continuous curvature with uniform durometer to seal back against the laryngo pharynx and to seal forward against the laryngeal inlet without an adhesive joint.

The present disclosure also relates to a method of using an airway management device. The method may include providing a removable connector/adapter on the linear portion to reduce the length from the proximal opening of the body up to the trachea to provide additional insertion depth of the distal tip of the endotracheal tube. Also disclosed is a method of using an airway management device including providing a finger stop that forms a fixed position for resting a thumb during insertion, to grasp the proximal end when the device is removed after intubation, and to serve as a depth indicator relative to the teeth when the device is in place.

The present disclosure also relates to a method of forming an airway management device. The method includes providing a body including a polypropylene copolymer (PP) and a thermoplastic elastomer benzene (TPE) ethylene-ethylene/butylene-styrene (SEBS). The body includes a shell molded from a primarily PP copolymer blended with SEBS, the shell extending from a proximal opening to a distal tip of the body.

The method may further comprise the step of attaching an intermediate strip moulded from a polypropylene copolymer to the housing intermediate the curved and straight portions of the body. Still further, the method may include providing a first SEBS overmold including an initial rear profile and a distal profile overmolded onto the housing, a distal perimeter of the first overmold defining first opposing edges of an overmolded cuff membrane extending tangentially from the distal perimeter in an annular curve having end points in spaced relation to and orthogonal to the first opposing edges, the end points collectively defining a rear opening perimeter or second opposing edges and overmolding the proximal end with a straight portion, such that the curved portion and the straight portion are joined into a single molded piece with the lateral side ground plane seal voids of the medial strip. The method may further include the step of providing a second SEBS overmold closing the membrane, thereby forming an inflatable cuff and completing the body.

Independently of or in dependence on the foregoing, the present disclosure also relates to a method of forming an object, which may be applied to an airway management device, but which may also have broader application. The method includes injecting a first portion of a molded object over a first core associated with a fixture. After injection molding the first portion, the method includes moving a second core associated with the fixture to a deployed position. The method also includes injection molding a second portion of the object over the second core and the first portion.

In some embodiments, the step of moving the second core associated with the fixture to the deployed position includes rotating the second core relative to the fixture. In some embodiments, the method includes attaching the preformed part to the object. The method also includes placing the one or more removable cores into the object and placing the one or more removable cores within an injection mold prior to molding the second portion of the object. The method also includes overmolding a film as part of the second portion of the object.

The method may further comprise the step of injection molding a third portion of the closure and sealing membrane to form an inflatable portion of the object. The method may further include removing the removable core from the film of the object prior to injection molding the third portion.

In some embodiments, the step of injection molding the first part is done in a first mold comprising the fixture. The step of injection moulding the second part may be performed in a second mould comprising the fixing means. The step of injection moulding the third part to close and seal the membrane may be done in a third mould comprising the fixing means.

The method may further comprise the step of transferring the fixture from the first mould to the second mould between the steps of injection moulding the first and second parts of the object. The step of injection moulding the first part on the first core object associated with the fixture comprises forming a shell of the object. The method may further comprise the steps of moving the first core to release the proximal end of the object, and removing the object from the second core of the fixture. The method may include providing a body comprising a polypropylene copolymer (PP) and a thermoplastic elastomer (TPE) styrene-ethylene/butylene-styrene (SEBS), wherein the first portion comprises a shell molded from a primary PP copolymer blended with the SEBS during a first injection molding step, the shell extending from a proximal opening to a distal tip of the body. Any of these methods may be used to manufacture or form the airway management device.

Yet another aspect of the present disclosure is directed to an apparatus for forming an injection molded object. The apparatus includes a reconfigurable fixture that includes a first movable core on which a first portion of an injection molded object is formed and a second movable core on which a second portion of the injection molded object is formed. In some embodiments, the first movable core is adapted to rotate relative to the fixture, and the second movable core is also adapted to rotate relative to the fixture.

In some embodiments, the first removable core is adapted to be removably attached to a fixture. The first removable core may include a connector for connecting to a fixture, and a handle. The securing means may comprise a retainer, such as a spring, for retaining the second movable core in the deployed position.

Yet another aspect of the present disclosure relates to a method of manufacturing a airway management device. The method includes providing a tubular body having a straight portion and a curved portion, the tubular body including a plurality of supports adjacent a rear channel. The method further includes providing a middle strap engaged with the plurality of supports and overlying the rear channel. The method also includes overmolding a material onto the intermediate strip.

In some embodiments, the method comprises the steps of: (1) injection molding a first portion of a body of an airway management device over a first core associated with a fixture; (2) after injection molding the first portion, moving a second core associated with the fixture to a deployed position; and (3) injection molding a second portion of the body over the second core and the first portion of the body. The step of moving the second core associated with the fixture to the deployed position may include rotating the second core relative to the fixture.

In some embodiments, the method further comprises the steps of: the method includes placing one or more removable cores in the tubular body, placing the one or more removable cores within a second injection mold, and overmolding the removable cores with a film that is part of the second portion of the body. The method may further include removing the removable core from close proximity of the first and second cores, leaving the open membrane open, and overmolding the second portion with a third portion that closes and seals the open membrane to form the inflatable cuff on the tubular body. The method may further comprise the steps of moving the first movable core and removing the removable core to release the tubular body.

In some embodiments, the method may include placing the first material in one or more voids adjacent to the center strip having the first material. The method may further comprise the step of melting a portion of the intermediate strip comprising the second material so as to diffuse the first material into the second material.

Another aspect of the present disclosure relates to a method of forming an object. The method includes injection molding a first portion of an object on a first core associated with a fixture in a first injection mold. The method further includes placing the fixture in a second injection mold and injecting a second portion of the overmolded object over a second core associated with the fixture and partially or fully over the first portion. Further, the fixture is placed in a third injection mold and the third part is injection overmolded over the first and second parts.

In some embodiments, the first core is movable relative to the fixture, and further comprising the step of moving the first core after injection molding the first or second portion of the object. The step of injection moulding the second part of the object may comprise injection moulding on a second core associated with the fixture. The second core may be movable relative to the fixture, and the method may further include the step of moving the second core to the deployed position after the step of injection molding the first portion of the object and before the step of injection molding the second portion of the object.

In some embodiments, the method may further comprise the step of placing the one or more removable cores within a second injection mold prior to the step of injection molding the second portion of the object. The step of injection molding the second portion of the object may include overmolding an open film onto the one or more removable cores. The one or more removable cores may be removed from the second injection mold with the fixture. Further, the one or more removable cores may be removed from the open film after injection molding the second portion of the object and before injection molding the third portion of the object. The method may further comprise the step of closing and sealing the open membrane to form an inflatable portion of the object.

The disclosed apparatus and methods may be used to form any object, including but not limited to the present disclosure-airway management devices of any size, shape, or form.

Drawings

Fig. 1 is an isometric view of a body of an airway management device according to one embodiment;

FIG. 2 is an isometric view of an insert for the body of FIG. 1;

FIG. 3 is an isometric view of the body of FIG. 1;

FIG. 4 is an isometric view of the insert of FIG. 2;

fig. 5 is an isometric view of an oxygen supply adapter of an airway management device according to another embodiment;

FIG. 6 is a cross-sectional view of the body of FIG. 7;

FIG. 6a is a detailed cross-sectional view of the body of FIG. 7;

FIG. 7 is an isometric view of the body of FIG. 1;

FIG. 8 is an isometric view of the body of FIG. 1;

FIG. 9 is an elevational view of the body of FIG. 1;

FIG. 10 is a plan view of the body of FIG. 1;

fig. 11 is a front view of a body of an airway management device according to another embodiment;

FIG. 12 is a rear view of the body of FIG. 11;

FIG. 13 is a detailed cross-sectional view of the body of FIG. 12;

FIG. 14 is a detailed cross-sectional view of the body of FIG. 12;

FIG. 15 is an isometric cross-sectional view of the body of FIG. 12;

FIG. 16 is an isometric view of the body of FIG. 12;

fig. 17 is an isometric view of a receiving tube of the airway management device;

FIG. 18 is a rear side of the airway management device body;

FIG. 19 is a back side of the airway management device body;

FIG. 20 is a side elevational view of the body of FIG. 18;

FIG. 21 is a side elevational view of the body of FIG. 19;

FIG. 22 is a rear elevational view of the body of FIG. 18;

FIG. 23 is a rear elevational view of the body of FIG. 19;

fig. 24 is an isometric view of the body of the airway management device;

FIG. 25 is an isometric view of the body of FIG. 24;

fig. 26 is a front view of a body of an airway management device according to another embodiment;

FIG. 27 is a front view, partially cut away, of the embodiment of FIG. 26;

FIG. 28 is an enlarged end view in partial cross-section of the embodiment of FIG. 26;

FIG. 29 is a cross-sectional side view of the embodiment of FIG. 26;

fig. 30 is/presents a cross-sectional view of the embodiment of fig. 26 under different operating conditions;

FIG. 31 is a side view of another embodiment;

FIG. 32 is an isometric view of the embodiment of FIG. 31; and is

Fig. 33 and 34 are views of the airway management device in place.

Fig. 35-45 relate to a method of forming an object, such as the airway management device of fig. 1-34, using injection molding techniques.

Detailed Description

Referring now to fig. 1-34, various embodiments of airway management devices are disclosed. The airway management device includes a body 6, such as an airway tube (fig. 1 and 3) that extends from a proximal end 1 of the device to a distal end 2. A horizontal cross-section a-a (fig. 6) through the straight portion of the proximal airway tube shows the primary and

secondary passageways

3, 4 disposed on either side of the median plane. This configuration forms a housing that provides a first area moment that is greater than a similarly sized circular or elliptical cross-section. This provides sufficient flexural strength to the device, so that the device acts as an exoskeleton as compared to prior art devices in which most of the flexural strength comes from components within the device, thus representing the endoskeleton structure.

The insertion of the adapter (fig. 5 and 17) into the proximal opening of the airway tube facilitates connection to the oxygen supply and combination into a more rigid structure capable of coping with and facilitating the hoop forces during insertion. The parallel and sagittal plane relationship of these two passageways defines an additional partial posterior passage 5, which partial posterior passage 5 forms a laterally offset third passageway with the medial band (fig. 2 and 4) to facilitate gastric drainage.

Parallel to the median plane, the cross section a-a of fig. 6 travels downwards through an anatomically approximate curvature of about 101 degrees (fig. 9), whereupon it transitions from a closed cross section to an open cross section coinciding with the ventral opening of the device 7 (fig. 8 and 9), at which the primary and secondary passageways terminate in the form of openings. Within the opening, a main passage provides gas communication. The main passage 3 allows blind intubation when the adapter is removed (fig. 10). The secondary pathway 4 provides an endoscopic channel during blind intubation, and a secondary pathway for spontaneous breathing during blind intubation.

Continuing downward from this transition, the airway tube cross-section maintains the semi-circular profile of the partial posterior channel 5 until reaching the proximal end 8 of the median groove 9, a feature that coincides with the anterior or ventral opening. When looking forward towards the anterior plane (fig. 6 and 10), the median trough provides a progressively curved path for gastric drainage from the local posterior passage 5 through the median trough to the anterior side of the distal airway tube; aligning the gastric drainage pathway with the median plane of the distal tip 10; allowing the gastric drainage catheter or aspiration catheter to pass with minimal frictional resistance.

Attached to the rear of the airway tube is a middle strip (fig. 2 and 4) which exhibits a curvature in the sagittal plane that matches that of the airway tube and horizontal cross section 11, thereby providing geometric consistency and attachment to the airway tube (fig. 6 and 6 a). The proximal medial strip (fig. 9 and 10) is defined by a tubular feature 12, the tubular feature 12 serving as an entry point for a gastric drainage catheter or suction catheter; and when viewed from the side, the central axis of the tubular feature 12 is at an angle of about 23.5 degrees to a horizontal plane that coincides with the central axis 13 through the proximal end of the airway tube (fig. 9 and 21). When positioned on the airway tube, the intermediate strip covers the partial posterior channel 5, the partial posterior channel 5 being a substantially elongate recess which together define a third passageway which is the gastric drainage path. The intermediate strip, once positioned, is flush with the outer surface of the device body. The distal end of the medial strip terminates at the proximal end of the median slot 8. Continuing down to the distal end 2, the airway tube cross-sectional width and first moment of area gradually decrease. The horizontal cross section through this transition section exhibits a ventral concave curvature, i.e. the posterior profile 34 continues to hold the intermediate strip (fig. 2, 4 and 9) up to the distal end of the airway tube.

When combined with the elastic properties of the polyolefin material, the ventral concave curvature 33a parallel to the median groove and the ventral concave curvature 33b horizontally across the median groove create a compound curvature (fig. 15) or partial conical spring (belleville washer) that promotes the instantaneous elastic response of the polyolefin material during flexing; thereby maintaining contact between the rear airway tube and the rear laryngo pharynx during insertion without excessive force causing co-morbidity and soft tissue damage.

In purely mechanical terms, the distal end of the airway tube may be considered a fixed support, while the airway tube itself may be considered to act as a cantilever beam. The force exerted by the straight proximal portion of the airway tube during insertion is centrally bent and extended by a horizontal axis coincident with the two laterally opposed slots 23. The diameter of the primary passageway is larger than the diameter of the secondary passageway, allowing some degree of rotation about the medial axis of the proximal airway tube that can be transmitted as a twist through to the distal tip. SAD's using semi-rigid PVC materials as airway tubes operate in a viscous manner, i.e., they resist shear and exhibit linear strain (change in length versus original length) for the duration of the applied force when the force is applied. However, these forces are dispersed into the PVC material so that when the force is released, the PVC does not immediately respond and returns to its original state. This energy loss or hysteresis effect is a significant disadvantage of the prior art based on PVC materials. Polyolefin materials, such as polypropylene, exhibit an excellent viscoelastic response characterized by an elastic rather than a viscous response.

During insertion, the forces transmitted through the airway tube exhibit a circular motion. Thus, the hysteresis of the materials used in the prior art may prevent the distal tip from properly seating with the upper esophageal sphincter. The prior art describes the possibility of the distal tip entering the larynx, or the distal tip of the LMA or SAD may fold down, a phenomenon described as fold down. Unlike other LMAs or SADs, the present invention uses an airway tube that extends from a proximal end to a distal tip, and the form and function of the airway tube exploits the immediate viscoelastic response of rigid polyolefin materials. While other SADs describe ventral displacement of the distal tip relative to a dorsal or posterior reference point on the airway tube to better conform to the anatomy, the present invention provides a wide range of deflectable responses that eliminate the ventral displacement described by the prior art.

The raised step 14 is defined by projecting from the outer surface of the gastric drainage catheter opening closest to the adapter (fig. 16), with a corresponding cut-out (fig. 17) or notch 43 in the outer surface of the adapter. This raised step retains and prevents the adapter from separating from the airway tube (fig. 20).

When viewed from above towards the distal tip (fig. 7), the proximal end 12 of the gastric drainage catheter is aligned with the median plane of the airway tube, i.e. the two passageways share the median plane (fig. 7). It must be noted that the median plane of the airway tube is referenced to the lateral extremities of the airway tube and not aligned with the primary or secondary passageways. To provide a primary passageway with a sufficient inner diameter to accommodate insertion of the ETT and blind intubation, the third passageway is laterally offset and separated by an impermeable barrier (the posterior surface of the airway tube) to ensure simultaneous blind intubation and entry into the stomach.

As the central axis of the proximal opening (fig. 9) approaches the intersection with the central axis 13a of the adapter and the airway tube, the tubular cross-section gradually transitions to an oval shape and no longer presents a closed perimeter, with an open portion 15 to span the proximal airway tube (fig. 2). When the gastric drainage suction catheter is inserted through the tubular feature 12, the distal tip of the suction catheter will make tangential contact 16 with the posterior surface of the primary passageway (fig. 3). Further insertion deflects the suction duct laterally, striving to align with the support structure of the support, such as the rib 17 adjacent the rear channel or third passage in this region. The suction catheter can then be guided internally to exit at the distal tip of the device 20.

Proximally, the middle strap is attached by 4 latches 18 (2 on each side) positioned laterally, with the middle strap spanning over the airway tube. At the same time the intermediate strip narrows abruptly 19 at the cut plane where the transverse straight section of the airway tube ends and the curvature 6 begins. The support structure of the ribs 17 follows the curvature of the airway tube 6; the opposing ribs 11a (fig. 6a) integral with the middle strap provide alignment and minimal interference sufficient to provide the aforementioned attachment.

Ribs

11a and 17 taper and terminate at the proximal end of the median groove 8.

Having described the airway tube, intermediate strip and adapter (any or all of which may be made of a polyolefin material in one possible embodiment), the present description focuses on an inflatable cuff made of the same base polyolefin material compounded thermoplastic elastomer (TPE). This in itself provides a means of assembly for the devices described herein. The self-adhesive properties of TPE, adhering the intermediate strip to the airway tube and forming an open thin-walled cuff membrane by means of an initial injection molding process; the subsequent injection moulding process traps the open membrane and creates an airtight and inflatable cuff which is integral to the form and function of the device.

Looking forward from the front (fig. 11), the initial injection molding process is used to ring the oval TPE cuff membrane of the airway tube generally around the circumference of the distal airway tube. In a particular embodiment, the cuff membrane is characterized by: a distal tip having a curvature and width to facilitate a tubular distal opening of the third passageway 20 or gastric drainage catheter; a transverse end 21 defined by a curvature extending above and tangentially to the distal tip; the rate of change of curvature increases, which at the median plane 22, just above the horizontal axis by two transversely opposite slots 23, closing an elliptical shape; and a closed third passageway or gastric drainage catheter 24 which completely covers the median groove 9 and has a contour and curvature 31 which conforms to the contour and curvature of the local posterior channel 5. It will be appreciated that in alternative embodiments, the membrane may be a variety of open shapes, which may allow closure by a second molding process to seal the open membrane, allowing the cuff to inflate.

Horizontal cross-sections B-B and C-C (fig. 13 and 14) show ventral or anterior openings 7 through which the primary and secondary passageways exit. With respect to fig. 14, the perimeter of the ventral opening is defined by a thin-walled inflatable cuff membrane presenting an oval segment 25. First adhered to the periphery of the distal airway tube 26 and continuing tangentially from the immediate front of the airway tube to its lateral ends and orthogonal to the edges of the airway tube. The method of manufacture requires that the cuff membrane be open along the peripheral posterior opening 27 (fig. 12 and 14), except for the region surrounding the distal opening of the gastric drainage catheter (fig. 13), which is molded to define a closed segment 28 surrounding the configuration of the inflatable cuff of the distal drainage catheter. To this end, as a result of the first injection molding step, the inflatable portion or cuff is in the form of an open annular shape having a membrane opening along an annular periphery and adjacent to the periphery of the airway tube.

Referring to fig. 8, the thickness of the airway tube along the perimeter 26 varies from 1.00mm at position 26a to 0.5mm at position 26b, in combination with the compound curvature 33 at the distal airway tube, providing a flexural hinge rather than the distal tip flexing about a fixed horizontal axis. The thickness of the inflatable cuff membrane varies between 0.25mm (the leading edge of the posterior opening 27) and 1.50mm along the circumference of the distal airway tube 26. All other cuff membrane wall thicknesses are optimized to provide the desired inflated shape and mechanical strength, for example, the portion of the inflatable cuff membrane (fig. 11, 20 and 21) surrounding the small tubular port 29 for attachment of the inflation catheter 29a is extruded from a thermoplastic elastomer (fig. 24 and 25) and is equipped at its proximal end with an inflation balloon 29b and a check valve allowing gaseous communication with the inflatable cuff.

In some embodiments, the distal portion of the gastric drainage catheter may not intersect the inflated volume of the cuff (fig. 13 and 14). In this embodiment, the outer diameter may not be directly exposed to the inflation pressure within the inflatable cuff; the wall thickness of the gastric drainage catheter does not require a reinforcing structure to prevent clogging; thereby avoiding a spherical distal cuff configuration. Alternatively, and in concert with the closure section 28, the inflatable cuff membrane 25 is molded as a closed tubular section 30 concentric with the third passageway or gastric drainage catheter 24, forming a free space or lumen 32 near the tip of the device and between the inflatable membrane and the distal third passageway, particularly around the hole through which the gastric drainage catheter protrudes. After seating and inflation, the closed section 30 of the cuff membrane does not expand to the point where all free space or cavity 32 is eliminated and the gastric drainage catheter 24 is compressed and occluded. Thus, the free space or cavity 32 provides an inflation cushion, the size of which can be determined by design to accommodate adequate inflation of the cuff. Thus, the cuff will inflate to its vicinity, providing support for the third passageway or gastric drainage catheter 24 and the distal opening 20 against the upper esophageal sphincter.

Further, immediately above the distal opening, the anterior portion of the distal airway tube compound curvature 33 defines an interior posterior surface of a third passageway or gastric drainage tube; the narrow width and curvature of the airway tube; a tapered thickness 26 b; and a surrounding profile 34 of self-adhesive TPE elastomer, minimizes the thickness of the distal tip deflation. Now aided by the softer TPE, the elastic response of the polyolefin airway tube is manifested at the distal tip. This configuration keeps the combined thickness of the materials to a minimum, a feature that is evident when the cuff is deflated prior to deployment, eliminating the potentially spherical nature of the distal cuff and gastric drainage support structure.

The TPE of the closure segment 28, which has been defined to adhere to the distal anterior airway tube (fig. 13), proceeds up the progressive curvature 31 of the median groove 9, smoothly fusing the resulting posterior profile 35 to the medial strip where it is positioned against the proximal end 8 of the median groove. At this junction, the TPE turns either side of the middle strip (fig. 7 and 12), filling the sagittal plane void 36 defined by the middle strip positioned against the posterior curvature of the airway tube 6. Proximally, at the junction of the abruptly narrowing intermediate strip 19, the TPE 37 converges to entirely encircle the latch 18 and the intermediate strip, where it crosses the airway tube; the combination of the intermediate strip and the airway tube is completed. Surrounded by TPE, and sealingly bonded to form a closed third passageway or gastric drainage catheter having a proximal opening and a distal opening.

The angle of the tubular feature relative to the adapter (fig. 16 and 17), combined with the elastic properties of the TPE, allows the user to: leverage is applied to the tubular feature 12 in a direction 40 such that the angle of incidence through the retaining step 14 relative to the front plane (fig. 9) decreases; the adapter is removed for insertion of an endotracheal tube or endoscope.

The adapter may be returned to its original position by inserting the distal end into the proximal airway tube opening 42 and pushing it back. Once the notch 43 in the adapter meets the raised step 14 on the tubular feature 12, a modest increase in pressure will snap the adapter back into place; the mating face 44 (fig. 5) of the adapter is pressed into and creates an airtight seal against the TPE45, which TPE45 covers the proximal 1 airway tube and the middle strap; a cylindrical cutout 46 in the adapter provides minimal clearance against the tubular feature 12.

The subsequent injection molding process provides a core and cavity that securely positions the leading edge of the open cuff membrane over the airway portion, such as the posterior distal airway tube perimeter 26. The TPE interacts with the front peripheral edge, entraps them and fuses with the already completed distal closure segment 28 and conforms to the final inflatable sleeve cuff profile defined by the injection molded core and cavity to close the annular cuff. Another embodiment of this interaction (fig. 12) encourages the TPE to further entrap the leading edge through a small incision 47 and adhere it directly to the back of the distal airway tube.

The final profile of the distal portion (fig. 18, 20 and 22) adds additional TPE over the initial posterior profile 35 of the airway tube, wrapping around the airway tube and completing the sealing perimeter 48 of the airway tube; an airtight inflated cuff is formed. Another embodiment of such perimeter fusion (fig. 19, 21 and 23) shows that the step 49 tapers to form a smooth fusion 50 around the perimeter of the airway tube.

The completion of the inflatable cuff membrane completes the manufacture of the device of the present invention without the need for adhesives or solvents. The complete use of polyolefin-based materials enables a more ecologically sustainable alternative to PVC and vinyl elastomers, which may contain DEHP plasticizers, or LSR, which cannot be recycled and similarly reprocessed, since it is a thermoset material whose crosslinking cannot be reversed during the molding process.

In accordance with another aspect of the present disclosure, and with reference to fig. 26-34, in some embodiments, the body 6 may comprise a thin wall molded from a primary polypropylene random copolymer blended with a small amount of SEBS that forms a dispersed elastomeric phase within the polypropylene (Abreu FOMS, Forte MMC, Liberman sa. Such a thin-walled moulding is interchangeably referred to hereinafter as a housing when discussing the mechanical structure of the body as a lever, and interchangeably as an airway tube when referring to the function of the body 6 as a breathing tube or passageway.

Specifically, according to one embodiment, the initial posterior profile 35 may comprise SEBS over-molded onto the shell that flows into the cuff membrane 25 forming an inflatable cuff. Due to mutual solubility, the SEBS diffuses into the polypropylene and likewise, the polypropylene diffuses into the SEBS, creating an intermingled polypropylene and SEBS interphase along the perimeter of the distal airway tube 26, creating a first opposing edge. At the same time, the straight portion is overmolded to the proximal end 37, so that the curved or initial rear profile 35 and the straight portion 37 are combined into a single molded piece with the sealing gaps 36 to the left and right of the middle strip 38. The first overmolding is done without adhesive bonding or welding of the discrete components, followed by a second SEBS overmolding of the rear opening perimeter 27 or second opposing edge of the sealing cuff membrane 25. The second overmold covers the original rear profile 35 with additional SEBS, closes with a sealing perimeter 48 and seals the bladder membrane. As described above, the body 6 has been effectively "assembled" in the mold using three separate injection molding processes, and all of the required fluid communication channels and inflatable cuffs are now completed.

As shown in figure 33, the inflatable cuff is used to seal the upper esophageal sphincter 70, but when the distal end 2 of the body 6 is wedged into the upper esophageal sphincter 70, the distal portion of the inflatable cuff must include a mechanism to reduce compression of the glottic inlet along the anterior-posterior axis. Fig. 29 shows a cross-section through the distal end 2. The distal rear profile 34 of the distal end 2 overmoulds the compound curvature 33 of the shell. The TPE overmolded distal profile 34 extends upwardly, merging with the initial posterior profile 35 and the distal perimeter of the shell or first opposing edge 26. This extension or closure section 28 (section C-C in FIG. 26) completes the third passageway or overmolded distal portion of the gastric drainage catheter 24. The anterior portion of this compound curvature 33 defines the inner diameter and course of the gastric drainage catheter 24; terminating in a distal opening 20. As the distal posterior profile 34 and the closure segment 28 are positioned and pressed against the laryngo pharynx 74, this upward displacement of the distal portion by increased esophageal pressure 71 (fig. 34) is prevented by the distal to proximal full length configuration and anatomical curvature of the intra-pharyngeal body 6. The softer distal posterior profile 34 and distal opening 20 wedge into the upper esophageal sphincter, maintaining an effective esophageal seal.

Upon cuff inflation, the gastric drainage tube 24 and the drainage tube distal opening 20 do not shift forward because they are integral with the distal rear contoured portion 34 pressing against the laryngo pharynx 74, i.e. the third passageway or gastric drainage tube 24 is not surrounded by an annular volume within the inflated cuff (fig. 29), and in view of this, reinforcement by the inflated cuff is not required to prevent occlusion. Only the distal portion of the cuff membrane of the closure segment 30 that is molded to be concentric with the gastric drainage catheter 24 is displaced forwardly. The lumen 32 formed by the closed section 30 provides space for the distal portion 30 to accommodate anatomical structures that are displaced rearwardly upon inflation, rather than pushing the glottis 66 forwardly.

In this embodiment, the non-inflatable volume of the pharyngeal body 6 is reduced, since the required elastic and flexural response is provided by a thin-walled shell, rather than by an assembly of multiple components having different stiffness and thickness. All points (or gaps between all points) in close proximity delineating the periphery of the distal airway tube 26, orthogonal to those points delineating the leading edge (or first and second opposing edges, respectively) of the open cuff membrane 27, are closed by the second overmold, creating an inflatable cuff. The cuff seals back against the laryngo pharynx 74 and forward against the laryngeal inlet 65 by means of the single inflatable membrane 25, without an adhesive joint (figure 30). Effectively maximizing the surface area of the inflatable cuff and minimizing contact of the non-inflatable surface (the surface without elastic recoil) with the anatomical structure, thereby minimizing direct compression of the non-inflatable surface against the neural structure.

Nerve damage is multifactorial, with an inflatable cuff being an important contributing factor, either being too stiff during insertion or pressing directly against neural structures in place. The cuff membrane 25, which is overmolded and integral with the body 6, exhibits resiliency and measured elasticity during insertion. The cuff membrane may be deflated to present a flat wedge shape for ease of insertion between the teeth, through the tongue and through the palatoglossal arch. For a given tension, the ability of a SEBS to stretch or elongate beyond its original length may be limited by the relative amounts of hard and soft domains in the individual polymer strands; upon inflation, the soft domains provide elasticity and conform to the anatomy, and the hard domains ensure resiliency and conform to the molded shape. LSR or PVC elastomers, which are single domain, tend to expand anterolaterally when encountering anterior-posterior resistance, no longer have a molded shape and compress neural structures, such as the lingual and sublingual nerves.

The cross-section B-B through the side cuff (FIG. 30) reveals a non-square relationship of height 51 to width 52, i.e., the height is always greater than the width. This non-square relationship, in combination with the cuff membrane 25 maintaining the as-molded shape, creates an initial anatomical seal at low inflation pressures or when the pressures inside and outside the cuff membrane 25 are equal. The same non-square relationship is maintained after inflation 25a, ensuring that anterolateral cuff inflation is reduced.

Referring to fig. 26, the curvature of each lateral end or curved perimeter 21 merges tangentially at its intersection with the median plane 22. Both lateral portions of the cuff 53 merge into the proximal portion 54, the ventral opening 7 adopting a rectangular configuration, wherein each merge 55 is an arc of equal radius; respectively, a continuation of the inner radius 56 of the first passageway and the radius 57 of the secondary passageway shown in fig. 28. A line 58 passing through the center of each radius blend 55 at 70 degrees on either side of section a-a creates a 140 degree vertical angle. Section F-F of fig. 26 and 27 is a planar section through one of the lines 58. The closed two-dimensional cross-sectional area of the cuff membrane 25 is the smallest of all other non-square cross-sections through the cuff membrane. Upon inflation (fig. 27), both transverse portions 53 and proximal portion 54 expand, pressing against each other at this section F-F so that each fusion 55 becomes a fold 59 and retains ventral opening 7 in the first aperture, in so doing limiting the over-inflation of the proximal portion of inflatable cuff 25 against the base of tongue 75; the proximal portion of inflatable cuff 25 remains aligned with and pressed against the end of epiglottis 76 (FIGS. 33 and 34).

Intubation with endotracheal tube (ETT)61 requires distal end 62 to exit ventral opening 7, through laryngeal inlet 65, and to be aligned with glottis 66 when the patient is in the reclined position (fig. 34). As the ETT 61 continues to pass down the glottis, the distal end 62 of the ETT 61 must be properly aligned with the trachea 68 (fig. 33 and 34). In general, the length of the airway tube from the proximal opening 42 to the ventral opening 7 should be kept to a minimum so that the distal end 62 of the ETT can be positioned well below the glottis 66. To facilitate meeting this minimum requirement, pressure is applied over the tubular port 12 to release the raised step 14 holding the connector 39 (fig. 31-33).

The most efficient path or conduit for cannulation and gastric drainage occupies the same anatomical space intermediate the ventral opening 7 and the proximal opening of the combined primary and secondary passageways 42. Their relative relationship contributes to the overall bulk of the device. Due to the limited space available in oropharynx 73 and to avoid pressure nerve damage from subject 6, an anatomically similar curvature is used, with preference given to the first or main channel 3 occupying the space closest to the median plane 22 of subject 6, albeit slightly offset from said median plane (fig. 28).

A third pathway for gastric drainage is symmetrically opposite and parallel to the first pathway 3, with the planar voids 36 on either side of the intermediate strip 38 defining this offset. The third passageway for gastric drainage does not merely occupy the interior space of the airway tube, but rather is a structural component, i.e., it contributes to the overall flexural strength of the outer shell of the body 6, allowing the wall thickness of the main passageway 3 to be minimized, thereby facilitating maximization of the interior space for intubation. The SEBS filling the planar voids 36 creates an intermediate phase of intertwined polypropylene and SEBS along the entire length of the anatomical curvature depicted by the support ribs 17 and the intermediate strips 38. During insertion, the bending and elongation applied to the proximal end of the body 6 are dissipated as shear, absorbed by the aforementioned mesophase of the median strip 38 bonded to the body 6.

The combined width of the body 6 may be symmetrical about the median plane 22. The nominal (e.g. 1.00mm) wall thickness of the housing reduces the overall volume and maximises the internal diameter of the first passageway 3, achieving an adult ETT 61 of typical internal diameter of 8.5mm for a size 4 device. The removable connector/adapter 39 reduces the length from the proximal opening 42 of the body 6 to the trachea 68, providing additional insertion depth of the ETT 61.

If an ETT 61 comprising a semi-rigid curved PVC tube is inserted into the proximal opening of the body 42 with the curvature of the tube oriented as if a laryngoscope were used (the ETT curvature follows the anatomical curvature), the exit of the ETT distal tip 63 upon entering the laryngeal inlet 65 will be directed toward the thyroid cartilage 69, rather than the glottis 66. However, by grasping the receiving tube 12 to lift the proximal opening 42 of the body 6 forward, the exit trajectory of the ETT distal tip 63 from the first passageway 3 through the ventral opening 7 and into the laryngeal inlet 65 can be optimized. As shown in fig. 34, the distal tip 61 of the ETT 62 may exit the ventral opening 7 and enter the laryngeal inlet 65 in closer alignment with the trachea 68. Since the ETT is made primarily of PVC, which is characterized by a viscous polymer, the force of bending the ETT axis 61 through the main or first passage 3 creates a curvature having an equivalent radius that is less than the predetermined curvature of the ETT axis 61. The energy required to bend the ETT shaft 61 is dissipated into and through the length of the shaft. When the ETT distal tip 63 exits the ventral opening 7, the protruding distal tip 63, including the balloon 62, attempts to return to its original curvature. However, recovery is not immediate.

This loss of energy or delayed recovery facilitates alignment of distal tip 63 with glottis 66. As the ETT distal tip 63 further enters the laryngeal opening, the lost energy is recovered, allowing the shaft of ETT 61 to partially straighten. During recovery, the body 6 may be lifted forward by grasping the receiving tube 12 to align the ETT distal tip 63 with the glottis 66. Thereafter, the ETT 61 is further inserted; distal tip 63 passes through vocal cords 67 and into trachea 68. The connector/adapter 64 is then removed from the tubular shaft of the ETT 61. The inflatable cuff 25 is deflated and the body 6 is removed, leaving the inflatable cuff in place. Thereafter, the ETT connector/adapter 64 returns to its previous position. The viscous nature of the ETT catheter body enables progressive and atraumatic recovery of the curvature.

According to another aspect of the present disclosure, a method of manufacture is also disclosed. By way of background, conventional injection molds include a core that generally defines a recess or interior of the molded part and a cavity that defines a protrusion or exterior of the molded part. The molten polymer is injected into the mold by a single screw/plunger mechanism. As the polymer is allowed to cool and solidify, it shrinks onto the core and is removed therefrom. A second screw mechanism may be added so that a polymer having two different colors or two different polymers may be injected into the mold sequentially in most cases.

The necessary mold is characterized by the complexity of molding the initial part with the first polymer; the core is then rotated by some contained mechanism to be overmolded with the second polymer. Typically, the two cores are identical, but the corresponding cavities are different; the first cavity depicts the geometry of the base or base part and the second cavity depicts the final overmold. With reference to multi-part molding, it is also possible to incorporate and overmold parts separate from the process, extending the definition to in-mold assembly. Technically, the range of applications using this approach is limited to relatively small prismatic components and subassemblies, as the applications are limited to the physical constraints of a single injection molding machine. This complexity of sequentially interacting molds can be described as a rigid body system, each requiring kinematic constraints, i.e. the interaction between the core and the cavity of each mold set is a prismatic pair with a single degree of freedom (mold opening and closing), and the interaction between subsequent processes within the molding machine frame is a pair (core rotating to the next cavity when the mold is open). Both constraints are characterized by a single degree of freedom.

From the above embodiments, synthesis of the design features is achieved by mold cores, which reduces the feature volume of the distal tip, reduces compression of the glottic inlet along the anterior-posterior axis, reduces the risk of nerve injury, and defines the non-square relationship of the inflatable cuff membranes 25, each core being a rigid body and the cores collectively being a rigid body system. Referring to fig. 35-45, the fixed frame 90 is a rigid body that is constrained. Each mold core is joined, aligned or linked to a stationary frame 90 by a kinematic pair or mechanism. Each kinematic pair refers to a kinematic constraint between each pair of rigid bodies that limits the movement of one rigid body relative to the other. The constraints are planar or spatial degrees of freedom (DOF), i.e. linear or rotational displacement. The unconstrained rigid body has a linear displacement in 3 axes and a rotational displacement in each of these axes; a total of 6 DOF (degrees of freedom). The total amount of displacement of the kinematic pair is sufficient to remove the completed body 6 from the rigid body system (hereinafter referred to as the system).

The body 6 is not conceived to display symmetric simple solid primitives; the free geometric complexity of the passageways or fluid paths within the body 6 requires that the mold core be capable of linear and rotational displacements, and combinations thereof, that vary from one DOF to six DOF. It is this complexity that distinguishes it from multi-part molding or in-mold assembly. Instead of in-mold assembly using a single injection molding machine, the body 6 is manufactured by transferring the system through a series of injection molding machines. In this embodiment, three injection molding machines (processes) are required. The housing is the initial base or base component (first injection molding process), the initial posterior profile 35, the sagittal plane void 36 with the medial strip 38, and the linear portion 37 are the first overmold (second injection molding process). The initial back contour 35 and the planar void 36 then become the base, and the sealing perimeter 48 is the second overmold (a third injection molding process).

In mold assembly, the degrees of freedom associated with mold configuration are limited, thus limiting the complexity of the molded article while creating a very complex injection molding process. To achieve the described design synthesis, the fixed frame 90 must be removable, transferable between injection molding machines, and itself contribute to precise interlocking during each injection molding process. Subsequently, in the space between the molding machines, additional components may be introduced, adding, removing or displacing the molding cores by linear or rotational displacement or a combination thereof, without the kinematic constraints inherent in the physical dimensions of the individual molding machines. The fixed frame 90 is used as a reference for all processes until the completed device is removed from the fixed frame 90 using a stripper mechanism. In essence, the body 6 is assembled by transfer of the system between an injection molding process and a non-injection molding process, each step of the assembly being either an injection molding process or an in-mold assembly. The non-injection molding process allows for the use of a larger DOF than the in-mold assembly to manipulate the system mechanism and introduce external components.

Starting from fig. 35 and 36, the first rotary core 91 is a revolute pair constrained by a first pivot 97. The revolute pair follows a single DOF that allows the first rotary core 91 to rotate about an axis defined by the first pivot 97. Similarly, the second rotary core 92 is a revolute pair constrained by a second pivot 98. The proximal core 94 is a prism pair that allows linear displacement in one direction and provides a single DOF through a sliding mechanism shared with the fixed frame 90.

At the beginning of the manufacturing process, and as shown in fig. 35 and 36, the rigid body system is placed into a first injection mold to mold the housing. At this point, the rigid body system is in static equilibrium. The first rotary core 91 is constrained by a pivot 97 and its rotation is defined by a proximal core 94 and a second rotary core 92, the position of the second rotary core 92 being fixed by a holder which may comprise an angular face on the pivot 98 against a leaf spring 103. When manually lifted by the handle 104, the mass of the system is supported by the proximal core 94 bearing the first rotary core 91, the first rotary core 91 in turn bearing the second rotary core 92, the second rotary core 92 being fixed by the corner face on the second pivot 98 bearing the leaf spring 103.

Fig. 37 shows the housing molded onto the first rotary core 91 and the proximal core 94. After the system is removed from the first mold and before being placed in the second injection mold (the second injection molding process being a first overmolding), the second rotary core 92 is rotated to the position shown in fig. 38 by releasing the leaf spring 103. The distal core pin 93 is also introduced as a rigid body that is unconstrained relative to the fixed frame 90. This distal core pin 93 fits into an angled channel 105 in the fixed frame 90 and locks into place. Note that the support ribs 17 of the intermediate strip 38 will be positioned.

Fig. 39 illustrates the middle strap 38 oriented for attachment to the housing. The latch 18 helps secure the middle strap 38 to the housing. Since the effective path of the intubation tube and gastric drainage takes up the same space, the intubation tube takes precedence and part of the third pathway 5 (the third pathway or the middle part of the gastric drainage catheter 24) is offset through the middle part of the body. At the proximal and distal ends of the third passage, the tubular port 12 and distal tip 26a/b of the housing are realigned with the central axis. This realignment and angular configuration of the tubular port 12 with respect to the partial posterior channel 5 prevents the use of the moulding core, since there is no tool to remove the moulding core. Furthermore, the intermediate strip 38 is uniquely characterized in that it is overmolded without any means of resisting deformation due to the heat and pressure of injection molding, other than the support ribs 17.

The system is placed into a second injection mold for the first overmolding. An unconstrained rigid body, such as first removable core 95 and second removable core 96, is also placed in the second injection mold. As shown in fig. 41, the closing of the mold positions the

removable cores

95 and 96 adjacent to the first rotary core 91 and the second rotary core 92. Fig. 42 shows the subsequent overmoulding of the shell into a complete body 6 with intermediate strips 38, inflatable cuff membranes 25, planar voids 36 and straight portions 37. Note the rear opening 27 of the cuff membrane 25. The system is then removed from the second injection mold.

When first removable core 95 and second removable core 96 are overmolded with a material such as SEBS (forming the encapsulation film 25), they are initially constrained by the film. These

removable cores

95 and 96 are unconstrained rigid bodies relative to the fixed frame 90, removed through the open cuff membrane by an external mechanism capable of utilizing the six degrees of freedom shown in fig. 43.

Thereafter, the system is transferred to a third injection mold where the open pocket film 25 is closed against the original posterior profile 35 and then overmolded to create the sealing

perimeters

48 and 49 shown in fig. 44. Fig. 18-22 illustrate other embodiments of such a sealing perimeter. This sealing perimeter is the second overmold. Further embodiments are not limited by the number of additional overmolding processes, as the assembly in the mold is assembled by a series of molding processes in a single injection molding machine, rather than in the mold assembly, which means that there are multiple molds in a single injection molding machine. The system can be transferred to the second process without motion constraints.

As described above, a unique feature of the intermediate strip 38 is that it is overmolded without any tools to resist deformation due to the heat and pressure of injection molding. For purposes of illustration, the middle arc 106 shown in FIG. 44 represents a middle arc segment of the body 6. The middle arc segment 2X is common to any plane perpendicular to the point along the middle arc and the center point of the equivalent radius of the middle arc 106. The medial concavity or diameter of the medial strip 38 is the same as the cross-sectional diameter of the partial posterior channel 5 in the main body 6; each intermediate arcuate segment through the intermediate strip 38 represents a simply supported beam. During overmolding, the sagittal plane void 36 is filled with a material such as SEBS. The outer edge of the medial band 38 parallel to the sagittal plane gap 36 tapers to a fine edge 38 a. As shown in the partially enlarged section 6X of fig. 44, these fine edges 38a serve as shields for protecting the support ribs 17. At the expense, the heat from the first overmolding process will melt the delicate edge 38a of the polypropylene medial strip 38, diffusing it into the SEBS filling the sagittal plane void 36. Furthermore, the pressure against the fine edge 38a presses it against the support rib 17, further sealing the third passage. The fine edge 38a also increases the surface area of the overmolding to better secure the center strip 38.

Finally, in order to remove the finished body 6 from the fixed frame 90, the respective cores defining each channel or fluid path are functionally displaced along a limited path with respect to the fixed frame 90, which remains stationary. In fig. 45, the first rotary core 91 is rotated by 90 degrees, and the proximal core 94 is linearly displaced to release the proximal end of the main body 6. Distal core pin 93 is initially constrained by the overmolding material presenting a planar pair. Distal core pin 93 is surface treated to reduce friction so that it can transform into an unconstrained rigid body when it is removed from body 6. Finally, the body 6 remains attached to the second rotary core 92, the kinetic constraint being a cylindrical pair. The rotation around the portion of the second rotary core 92 defining the closed tubular section 30 and the linear displacement along the axis of this tubular section 30 allow the extraction of the complete body. The constrained rigid body returns to the configuration depicted in fig. 35 and the process is repeated.

In this embodiment, the assembly in the mold is a kinematic synthesis of the channels or fluid paths, wherein the channels are functionally independent and combined with each other by design, structurally dependent on each other as a whole.

As described, this synthesis is a combination of material compatibility, design features, and unique manufacturing methods.

The present disclosure may be considered as relating to any or all of the aforementioned items in any combination:

1. an airway management device comprising:

a body (6), the body (6) comprising a shell molded from a polypropylene copolymer (PP) blended with a thermoplastic elastomer (TPE) styrene-ethylene/butylene-styrene (SEBS), the shell extending from a proximal opening to a distal tip of the body (6), the shell having a curved portion (35) and a linear portion (37).

2. The airway management device according to item 1, further comprising an intermediate strip (38) molded from a polypropylene copolymer (PP), the intermediate strip (38) being attached to the housing intermediate the curved portion (35) and the straight portion (37).

3. The airway management device according to item 1 or item 2, further comprising a first SEBS overmold that includes a rear contoured portion (35) and a distal contoured portion (34) on the housing.

4. The airway management device according to any of clauses 1-3 wherein the first overmolded portion or the first overmolded portion includes a distal perimeter (26), the distal perimeter (26) defining a first opposing edge of the overmolded cuff membrane (25), the overmolded cuff membrane (25) extending tangentially from the perimeter (26) in an annular curve having endpoints in spaced relationship and orthogonal to the first opposing edge, the endpoints defining a rear open portion (27) perimeter or a second opposing edge and a straight portion (37) overmolding a proximal end, such that the curved portion (35) and the straight portion (37) are joined into a single molded piece by a planar sealing gap (36) of the first and second sides of the intermediate strip (38).

5. The airway management device according to any of clauses 1-4, further including a second SEBS overmold that closes an open length (27) of the membrane, forming an inflatable cuff.

6. The airway management device according to any of clauses 1-5, wherein the rear contoured portion (35) or the rear contoured portion (35) of the body (6) is adapted to be located in the laryngo pharynx and the distal end (2) is adapted to be located in the upper esophageal sphincter immediately above the distal opening (20) forming an esophageal seal, the anterior compound curvature (33) of the housing being the interior posterior surface of the tunnel or gastric drainage catheter (24) thereby reducing the distal tip (2) volume.

7. The airway management device according to any of clauses 1-6, further comprising a circumferential contour (34), the circumferential contour (34) overmolding the anterior compound curvature (33) of the shell, and the circumferential contour (34) adapted to be positioned and pressed against the laryngo pharynx, a full length distal to proximal configuration of the shell providing resistance against upward displacement of the distal opening (20) due to increased esophageal pressure (70).

8. The airway management device according to any of clauses 1-7, wherein the drainage catheter (24) or the drainage catheter (24) and drainage catheter distal opening (20) are integral with a distal posterior profile (34), and wherein the drainage catheter (24) is not surrounded by the annular volume of the inflatable cuff.

9. The airway management device according to any of clauses 1-8, further comprising a closed tubular segment (30), the closed tubular segment (30) forming a cavity (32) to provide space for a distal portion of the inflatable cuff to displace backwards when inflated.

10. The airway management device according to any of clauses 1-9, wherein across any horizontal cross section of the inflatable cuff, at least for the length of the distal portion of the gastric drainage tube (31), first and second edges (27) remain parallel to a median plane (10) of the curved portion (35), such that the width between the first and second edges (27) after the second over-molding is equal to the outer diameter of the distal drainage tube (31).

11. The airway management device according to any of clauses 1-10, wherein the curvature of the inflatable cuff membrane (25) between the first opposing edge (26) and the second opposing edge (27) is a single continuous curvature with uniform durometer to seal back against the laryngo pharynx and to seal forward against the laryngeal inlet without an adhesive joint.

12. A method of using the airway management device according to any of clauses 1-11, comprising:

providing a removable connector/adapter (39) on the linear portion to reduce the length from the proximal opening (42) of the body (6) up to the trachea (68), thereby providing additional insertion depth of the distal tip (63) of the endotracheal tube.

13. A method of using the airway management device according to any of clauses 1-11, comprising:

a finger stop (60) is provided which forms a fixed position for resting the thumb during insertion, to grasp the proximal end (37) when the device is removed after intubation, and to serve as a depth indicator for reference teeth when the device is in place.

14. A method of forming an airway management device, comprising:

providing a body (6) comprising a polypropylene copolymer (PP) and a thermoplastic elastomer (TPE) styrene-ethylene/butylene-styrene (SEBS), the body (6) comprising a shell molded from a primary PP copolymer blended with SEBS, the shell extending from a proximal opening to a distal tip of the body (6).

15. The method of item 14, further comprising the step of:

an intermediate strip (38) moulded from a polypropylene copolymer is attached to the housing intermediate the curved portion (35) and the straight portion (37) of the body (6).

16. The method of item 14 or item 15, further comprising the step of:

providing a first SEBS overmold including an initial rear profile (35) and a distal profile (34) overmolded onto the housing, a distal perimeter (26) of the first overmold portion defines a first opposing edge of an overmolded cuff membrane (25), the overmolded cuff membrane (25) extending tangentially from the distal periphery (26) in an annular curve, the endpoints of the circular curve are in spaced relationship with and orthogonal to the first opposing edge, the end points collectively defining a rear opening (27) perimeter or second opposing edge and a straight portion overmolding the proximal end (37), whereby the curved portion (35) and the straight portion (37) are united into a single molded piece by the planar sealing gaps (36) on both lateral sides of the intermediate strip (38).

17. The method of item 16, further comprising the step of:

providing a second SEBS overmoulded portion closing the membrane (25), forming an inflatable cuff and completing the body (6).

18. A method of forming an object comprising:

injection molding a first portion of the object over a first core associated with a fixture;

moving a second core associated with the fixture to a deployed position after injection molding the first portion; and

injection molding a second portion of the object over the second core and the first portion.

19. The method of clause 18, wherein the step of moving the second core associated with the fixture to the deployed position comprises rotating the second core relative to the fixture.

20. The method of item 18 or item 19, further comprising the step of:

attaching a preformed part to the object;

placing one or more removable cores into the object; and

placing one or more removable cores within the injection mold prior to molding the second portion of the object; and

overmolding a film as part of the second portion of the object.

21. The method of any of clauses 18-20, further comprising the step of injection molding a third portion of the film closed and sealed to form an inflatable portion of the object.

22. The method of any of clauses 18-21, further comprising the step of removing the removable core from the film of the object prior to injection molding the third portion.

23. The method of any of items 18-21, wherein:

the step of injection moulding the first part is done in a first mould comprising the fixing means; and is

The step of injection moulding the second part is done in a second mould comprising the fixing means; and is

The step of injection molding the third portion of the film closed and sealed is done in a third mold comprising the fixture.

24. The method of any of clauses 18-23, further comprising the step of transferring the fixture from a first mold to a second mold between the step of injection molding the first and second portions of the object.

25. The method of any of clauses 18-24, wherein injection molding the first portion of the object over the first core associated with the fixture comprises forming the outer shell of the object.

26. The method of any of items 18-25, further comprising the steps of:

moving the first core to release the proximal end of the object; and

removing the object from the second core of the fixture.

27. The method of any of items 18-26, further comprising the steps of:

providing a body comprising a polypropylene copolymer (PP) and a thermoplastic elastomer (TPE) styrene-ethylene/butylene-styrene (SEBS), and

wherein the first portion comprises a shell molded from a predominantly PP copolymer blended with SEBS during the first injection molding step, the shell extending from a proximal opening to a distal tip of the body.

28. The method of any of clauses 18-27, wherein the object comprises an airway management device.

29. An apparatus for forming an injection molded object, comprising:

a reconfigurable fixture including a first movable core on which a first portion of the injection molded object is formed and a second movable core on which a second portion of the injection molded object is formed.

30. The apparatus of clause 29, wherein the first movable core is adapted to rotate relative to the stationary device.

31. The apparatus of clause 29 or clause 30, wherein the second movable core is adapted to rotate relative to the stationary device.

32. The apparatus of any of items 29-31, further comprising a first removable core adapted to be removably attached to the fixture.

33. The apparatus of clause 32, wherein the first removable core comprises a connector for connecting to the fixture.

34. The apparatus of clause 32, wherein the first removable core comprises a handle.

35. The apparatus of any of clauses 29-34, wherein the securing device comprises a spring for maintaining the second movable core in a deployed position.

36. A method of manufacturing a airway management device, comprising:

providing a tubular body having a straight portion and a curved portion, the tubular body including a plurality of supports adjacent a rear channel;

providing a central strip engaged with the plurality of supports and overlying the rear channel; and

overmolding a material onto the intermediate strip.

37. The method of item 36, further comprising the step of:

injection molding a first portion of the body of the airway management device over a first core associated with the fixture;

injection molding a second portion of the body over the second core and the first portion of the body.

38. The method of clause 37, wherein the step of moving the second core associated with the fixture to the deployed position comprises rotating the second core relative to the fixture.

39. The method of any of items 36-38, further comprising the steps of:

placing one or more removable wicks in the tubular body;

placing one or more removable cores within the second injection mold; and

molding the removable core with a film coating as part of the second portion of the body.

40. The method of item 39, further comprising the steps of:

removing the removable core from close proximity of the first and second cores, leaving an open membrane; and

overmolding the second portion with a third portion that closes and seals the film to form an inflatable cuff on the tubular body.

41. The method of item 39 or item 40, further comprising the step of moving the first core and removing the removable core to release the tubular body.

42. The method of any of items 36-41, further comprising the steps of:

placing a first material in one or more voids adjacent to the middle strip having the first material; and

melting a portion of the intermediate strip comprising a second material so as to diffuse the first material into the second material.

43. A method of forming an object comprising:

injection molding a first portion of the object on a first core associated with a fixture in a first injection mold;

placing the fixture in a second injection mold; and

injection molding a second portion of the object.

44. The method of item 43, wherein the first core is movable relative to the fixture, and further comprising the step of moving the first core after injection molding the first portion or the second portion of the object.

45. The method of clause 43 or clause 44, wherein the step of injection molding the second portion of the object comprises injection molding on a second core associated with the fixture.

46. The method of any of clauses 43-45, wherein the second core is movable relative to the fixture and further comprising the step of moving the second core to a deployed position after the step of injection molding the first portion of the object and before the step of injection molding the second portion of the object.

47. The method of any of clauses 43-46, further comprising the step of placing one or more removable cores within the second injection mold prior to the step of injection molding the second portion of the object.

48. The method of any of clauses 43-47, wherein the step of injection molding the second portion of the object comprises overmolding a film onto the one or more removable cores.

49. The method of any of clauses 43-48, wherein the one or more removable cores are removed from the second injection mold with the fixture.

50. The method of any of clauses 43-49, wherein the one or more removable cores are removed from the film after injection molding the second portion of the object and before injection molding the third portion of the object.

51. The method of clause 50, further comprising the step of closing and sealing the membrane to form an inflatable portion of the object.

52. An airway management device formed by the method of any of clauses 36-51.

Deployment position as used herein, each of the following terms, written in the singular grammatical forms "a", "an", and "the", means "at least one" or "one or more". The phrase "one or more" as used herein does not alter the intended meaning of "a", "an", or "the". Thus, as used herein, the terms "a", "an" and "the" may also refer to and encompass a plurality of the recited entities or objects, unless the context clearly dictates otherwise, or the context clearly dictates otherwise. For example, as used herein, the phrases "unit," "device," "assembly," "mechanism," "component," "element," and "step or process" may also refer to and encompass, respectively, multiple units, multiple devices, multiple assemblies, multiple mechanisms, multiple components, multiple elements, and multiple steps or processes.

As used herein, each of the following terms: the terms "comprises," "comprising," "has," "having," and "containing," as well as language/grammatical variations, derivatives, and/or conjugates thereof, mean "including but not limited to," and are to be construed as specifying a stated component, feature, characteristic, parameter, integer, or step, and not precluding the addition of one or more additional components, features, characteristics, parameters, integers, steps, or combinations thereof. Each of the following terms is considered to be synonymously equivalent to the phrase "consisting essentially of … …". As used herein, each of the phrases "consisting of … …" and "consisting of … …" means "including and limited to. The phrase "consisting essentially of … …" means that the stated entity or item (system, system unit, system sub-unit device, assembly, sub-assembly, mechanism, structure, component element, or, peripheral equipment, accessory, or material, method or process, step or process, sub-step or sub-process), which is all or part of an exemplary embodiment of the disclosed invention, and/or which is used to implement an exemplary embodiment of the disclosed invention, may include at least one additional feature or characteristic: system unit system sub-unit devices, assemblies, sub-assemblies, mechanisms, structures, components or elements or, peripheral equipment facilities, accessories or materials, steps or processes, sub-steps or sub-processes, but only if each such additional feature or characteristic "does not materially alter the basic novel and inventive characteristics or the special technical characteristics of the claimed item".

As used herein, the term "method" refers to steps, processes, means, and/or techniques for accomplishing a given task, including, but not limited to, those steps, processes, means, and/or techniques known to, or readily developed from known steps, processes, means, and/or techniques by practitioners of the relevant art in the field of the disclosed invention.

As used herein, approximating terms (such as about, substantially, approximately, etc.) refer to ± 10% of the stated numerical value or as close as possible to the stated condition.

It is to be fully understood that certain aspects, features and characteristics of the present invention, which are, for clarity, illustratively described and presented in the context or arrangement of separate embodiments, may also be illustratively described and presented in any suitable combination or sub-combination in the context or arrangement of individual embodiments. Conversely, various aspects, features, and characteristics of the present invention which are illustratively described and presented in combination or sub-combination in the context or arrangement of a single embodiment can also be illustratively described and presented in the context or arrangement of a plurality of separate embodiments.

While the present invention has been illustratively described and presented by way of specific exemplary embodiments and examples thereof, it is evident that many alternatives, modifications and/or variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and/or variations that fall within the spirit and broad scope of the appended claims.

Claims

1. An airway management device comprising:

a body (6), the body (6) comprising a shell molded from a polypropylene copolymer (PP) blended with a thermoplastic elastomer (TPE) of styrene-ethylene/butylene-styrene (SEBS), the shell extending from a proximal opening to a distal tip of the body (6), the shell having a curved portion (35) and a straight portion (37).

2. The airway management device according to claim 1, further comprising an intermediate strip (38) molded from a polypropylene copolymer (PP), said intermediate strip (38) being attached to said housing intermediate said curved portion (35) and said straight portion (37).

3. The airway management device according to claim 1, further comprising a first overmolded portion of SEBS, the first overmolded portion comprising a rear contoured portion (35) and a distal contoured portion (34) on the housing.

4. The airway management device according to claim 3, wherein the first overmold portion includes a distal perimeter (26), the distal perimeter (26) defining a first opposing edge of an overmolded cuff membrane (25), the overmolded cuff membrane (25) extending tangentially from the perimeter (26) in an annular curve having endpoints in spaced relation to and orthogonal to the first opposing edge, the endpoints defining an open rear (27) perimeter or a second opposing edge and a straight portion (37) overmolded proximal end, such that the curved portion (35) and the straight portion (37) are combined into a single molded piece by a planar sealing gap (36) of a first side and a second side of an intermediate strip (38).

5. The airway management device according to claim 4, further comprising a second overmold of SEBS that closes an open length (27) of the membrane forming an inflatable cuff.

6. The airway management device according to claim 5, wherein the rear contoured portion (35) of the body (6) is adapted to be located in the laryngo pharynx and the distal end (2) is adapted to be located in the upper esophageal sphincter immediately above the distal opening (20) forming an esophageal seal, the anterior compound curvature (33) of the housing being the interior posterior surface of the tunnel or gastric drainage catheter (24) thereby reducing the distal tip (2) volume.

7. The airway management device according to claim 6, further comprising a circumferential contour (34), said circumferential contour (34) overmolding the anterior compound curvature (33) of the shell, and said circumferential contour (34) being adapted to be positioned and pressed against the laryngo pharynx, a full length distal to proximal configuration of the shell providing resistance against upward displacement of the distal opening (20) due to increased esophageal pressure (70).

8. The airway management device according to claim 6, wherein the drainage catheter (24) and drainage catheter distal opening (20) are integral with a distal posterior profile (34), and wherein the drainage catheter (24) is not surrounded by the annular volume of the inflatable cuff.

9. The airway management device according to claim 6, further comprising a closed tubular segment (30), the closed tubular segment (30) forming a lumen (32) to provide space for a distal portion of the inflatable cuff to displace rearwardly when inflated.

10. The airway management device according to claim 6, wherein through any horizontal cross section of the inflatable cuff, at least for the length of the distal portion of the gastric drainage tube (31), first and second edges (27) remain parallel to a median plane (10) of the curved portion (35), such that the width between the first and second edges (27) after the second over-molding is equal to the outer diameter of the distal drainage tube (31).

11. The airway management device according to claim 10, wherein the curvature of the inflatable cuff membrane (25) between the first opposing edge (26) and the second opposing edge (27) is a single continuous curvature with a uniform durometer to seal back against the laryngo pharynx and to seal forward against the laryngeal inlet without an adhesive joint.

12. A method of forming the airway management device of claim 1, comprising:

13. A method of forming the airway management device of claim 1, comprising:

14. A method of forming an airway management device, comprising:

providing a body (6) comprising a thermoplastic elastomer (TPE) of a polypropylene copolymer (PP) and styrene-ethylene/butylene-styrene (SEBS), the body (6) comprising a shell molded from a predominantly PP copolymer blended with SEBS, the shell extending from a proximal opening to a distal tip of the body (6).

15. The method of claim 14, further comprising the step of:

16. The method of claim 15, further comprising the step of:

providing a first overmolded portion of SEBS comprising an initial rear profile (35) and a distal profile (34) overmolded onto the housing, a distal perimeter (26) of the first overmold portion defines a first opposing edge of an overmolded cuff membrane (25), the overmolded cuff membrane (25) extending tangentially from the distal periphery (26) in an annular curve, the endpoints of the circular curve are in spaced relationship with and orthogonal to the first opposing edge, the end points collectively defining a rear opening (27) perimeter or second opposing edge and a straight portion overmolding the proximal end (37), whereby the curved portion (35) and the straight portion (37) are united into a single molded piece by the planar sealing gaps (36) on both lateral sides of the intermediate strip (38).

17. The method of claim 16, further comprising the step of:

providing a second overmoulded portion of SEBS closing the membrane (25), thereby forming an inflatable cuff and completing the body (6).

18. A method of forming an object comprising:

19. The method of claim 18, wherein the step of moving the second core associated with the fixture to the deployed position comprises rotating the second core relative to the fixture.

20. The method of claim 18, further comprising the step of:

attaching a preformed part to the object;

placing one or more removable cores into the object; and

overmolding a film as part of the second portion of the object.

21. The method of claim 20, further comprising the step of injection molding a third portion of the film closed and sealed to form an inflatable portion of the object.

22. The method of claim 21, further comprising the step of removing the removable core from the film of the object prior to injection molding the third portion.

23. The method of claim 21, wherein:

24. The method of claim 18, further comprising the step of transferring the fixture from a first mold to a second mold between the steps of injection molding the first and second portions of the object.

25. The method of claim 18, wherein the step of injection molding the first portion of the object over the first core associated with the fixture comprises forming the outer shell of the object.

26. The method of claim 18, further comprising the step of:

moving the first core to release the proximal end of the object; and

removing the object from the second core of the fixture.

27. The method of claim 18, further comprising the step of:

providing a body of a thermoplastic elastomer (TPE) comprising a polypropylene copolymer (PP) and styrene-ethylene/butylene-styrene (SEBS), and

28. The method of any of claims 18-27, wherein the object comprises an airway management device.

29. An apparatus for forming an injection molded object, comprising:

30. The apparatus of claim 29, wherein the first movable core is adapted to rotate relative to the fixture.

31. The apparatus according to claim 29 or 30, wherein the second movable core is adapted to rotate relative to the fixation device.

32. The apparatus of any of claims 29-31, further comprising a first removable core adapted to be removably attached to the fixture.

33. The apparatus of claim 32, wherein the first removable core comprises a connector for connecting to the fixture.

34. The apparatus of claim 32, wherein the first removable wick comprises a handle.

35. The apparatus of claim 31, wherein the securing means comprises a spring for holding the second movable core in a deployed position.

36. A method of manufacturing a airway management device, comprising:

overmolding a material onto the intermediate strip.

37. The method of claim 36, further comprising the step of:

injection molding a first portion of the body of the airway management device over a first core associated with a fixture;

38. The method of claim 37, wherein the step of moving the second core associated with the fixture to the deployed position comprises rotating the second core relative to the fixture.

39. The method of claim 37, further comprising the step of:

placing one or more removable wicks in the tubular body;

placing one or more removable cores within the second injection mold; and

40. The method of claim 39, further comprising the step of:

41. The method of claim 40, further comprising the step of moving the first wick and removing the removable wick to release the tubular body.

42. The method according to any one of claims 39-41, further comprising the step of:

43. A method of forming an object comprising:

placing the fixture in a second injection mold; and

injection molding a second portion of the object.

44. The method of claim 43, wherein the first core is movable relative to the fixture, and further comprising the step of moving the first core after injection molding the first portion or the second portion of the object.

45. The method of claim 43, wherein the step of injection molding the second portion of the object comprises injection molding on a second core associated with the fixture.

46. The method according to claim 45, wherein the second core is movable relative to the fixture, and further comprising the step of moving the second core to a deployed position after the step of injection molding the first portion of the object and before the step of injection molding the second portion of the object.

47. The method of claim 43, further comprising the step of placing one or more removable cores within the second injection mold prior to the step of injection molding the second portion of the object.

48. The method of claim 43, wherein the step of injection molding the second portion of the object comprises overmolding an open film onto the one or more removable cores.

49. The method of claim 48, wherein the one or more removable cores are removed from the second injection mold with the fixture.

50. The method of claim 49, wherein the one or more removable cores are removed from the open film after injection molding the second portion of the object and before injection molding the third portion of the object.

51. The method of claim 50, further comprising the step of closing and sealing the open membrane to form an inflatable portion of the object.

52. An airway management device formed by the method of any of claims 36-51.